FDA.reportPublic FDA data

Heart valve prosthesis sizer handle

Definition
A hand-held manual surgical instrument intended to be used during cardiac valve repair or replacement as a handle to which an interchangeable valve sizer is attached to allow the surgeon to evaluate the valve opening (patient annulus) into which the appropriate sized annuloplasty ring or replacement valve will be implanted. The device is typically made of metal and/or plastic (e.g., polysulphone) and is straight and/or curved, rigid and/or flexible in design; this handle may also be connected to the valve or ring holder to assist implantation. This is a reusable device.
GUDID devices
62
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05415067034526NAST. JUDE MEDICAL, INC.E2000-HA2022-12-21
05415067034533NAST. JUDE MEDICAL, INC.E2000-HM2022-12-21
00613994163516Annuloplasty HandleMEDTRONIC, INC.7615XL2025-12-22
00613994862488Annuloplasty HandleMEDTRONIC, INC.76862025-12-22
00643169525610Annuloplasty HandleMEDTRONIC, INC.76152025-12-22
00643169525634Annuloplasty HandleMEDTRONIC, INC.76862025-12-22
00643169525641Annuloplasty HandleMEDTRONIC, INC.7686XL2025-12-22
00643169624993NAMEDTRONIC, INC.5582025-12-22
00721902450358Valve HandleMEDTRONIC, INC.76392025-12-22
00885074394848Valve HandleMEDTRONIC, INC.76392025-12-22
00763000658960Profile 3D™MEDTRONIC, INC.7686L2025-08-21
00763000658953Profile 3D™MEDTRONIC, INC.76862025-07-19
00763000658977Profile 3D™MEDTRONIC, INC.7686XL2025-07-19
00613994163523Duran AnCoreMEDTRONIC, INC.7620HXL2025-05-30
00613994959546Open Pivot™MEDTRONIC, INC.5582025-05-30
00643169525627Annuloplasty HandleMEDTRONIC, INC.7615XL2025-05-30
00643169554139Valve HandleMEDTRONIC, INC.76392025-05-30
00643169554146Valve HandleMEDTRONIC, INC.7639XL2025-05-30
00643169624962Open Pivot™MEDTRONIC, INC.5692025-05-30
00643169739246Avalus™MEDTRONIC, INC.74202025-05-31
00763000612351Annuloplasty HandleMEDTRONIC, INC.76152025-03-20
00763000612368Annuloplasty HandleMEDTRONIC, INC.7615XL2025-03-20
00763000613648NAMEDTRONIC, INC.76392025-03-03
00763000613655NAMEDTRONIC, INC.7639XL2025-03-03
00763000582906Valve Handle 7420MEDTRONIC, INC.74202025-02-23
00851788001150On-X Heart Valve InstrumentsON-X LIFE TECHNOLOGIES, INC.ONXI2-H2023-08-09
00763000318345NAMEDTRONIC, INC.76392021-07-19
00763000318352NAMEDTRONIC, INC.7639XL2021-07-19
00763000318437NAMEDTRONIC, INC.76152021-07-19
00763000318444NAMEDTRONIC, INC.7615XL2021-07-19
00763000318468NAMEDTRONIC, INC.76862021-07-19
00763000318475NAMEDTRONIC, INC.7686XL2021-07-19
00763000334369NAMEDTRONIC, INC.7686L2021-07-19
00896208000078Mitroflow Aortic HandleCorcym Canada CorpAH-112021-04-08
08022057013989CARBOMEDICS PROSTHETIC HEART VALVESCORCYM SRLVH-1002021-04-02
08022057014023CARBOMEDICS PROSTHETIC HEART VALVESCORCYM SRLRH-1002021-04-02
08022057014030CARBOMEDICS PROSTHETIC HEART VALVESCORCYM SRLRM-3992021-04-02
00763000318581Medtronic Open Pivot™MEDTRONIC, INC.5692021-04-01
08022057014474UNI HANDLECORCYM SRLICV06642021-04-01
08022057015136Extended UNI HandleCORCYM SRLICV13422021-04-01
00763000137885NAMEDTRONIC, INC.76862019-06-07
00763000137892NAMEDTRONIC, INC.7686XL2019-06-07
05414734010108NAST. JUDE MEDICAL, INC.905-HH2015-11-13
05414734010115NAST. JUDE MEDICAL, INC.905-R2015-11-13
05414734010122NAST. JUDE MEDICAL, INC.905-RHH2015-11-20
05414734021180NAST. JUDE MEDICAL, INC.HH-8042015-11-02
05414734054072SJM™ST. JUDE MEDICAL, INC.Holder Handle2016-03-23
05415067000668NAST. JUDE MEDICAL, INC.UT20002016-03-23
05415067000675NAST. JUDE MEDICAL, INC.UT2000-R2016-03-23
05415067002020NAST. JUDE MEDICAL, INC.EX2000-R2015-12-04
05415067003911NAST. JUDE MEDICAL, INC.905-332016-03-23
05415067003942NAST. JUDE MEDICAL, INC.905-MHH2015-11-13
05415067009708NAST. JUDE MEDICAL, INC.EX-052015-11-02
05415067009715NAST. JUDE MEDICAL, INC.HH-052015-11-02
05415067009722NAST. JUDE MEDICAL, INC.MHV-HHL12015-12-04
05415067009739NAST. JUDE MEDICAL, INC.MHV-HHL22015-12-04
05415067009746NAST. JUDE MEDICAL, INC.MHV-HHL32016-02-01
05415067009753NAST. JUDE MEDICAL, INC.MHV-HHR2015-12-04
05415067018267Trifecta™ST. JUDE MEDICAL, INC.Valve Series Rigid Holder Handle2016-06-27
05415067018274Trifecta™ST. JUDE MEDICAL, INC.Valve Series Flexible Holder Handle2016-06-27
00763000044404NAMEDTRONIC, INC.7686L2019-01-24
00643169976405Avalus™MEDTRONIC, INC.74202017-10-14